Abstract
Background
Typography significantly influences the legibility and usability of patient information. This study investigated the implementation and changes of different typographic subjects in package leaflets used in the European Union.
Methods
A randomly selected sample of all German package leaflets investigated in 2005 was reanalyzed in 2015 for different important and predefined typographic subjects.
Results
The 138 package leaflets revisited in 2015 showed significant increases in word count (average 2551 words), font size (1.43 mm x-height, 2.0 mm cap-height), line spacing (3.13 mm), use of text attributes (for example, lists in 94.2% and bold print in 83.2% package leaflet’s body text), use of light-condensed or condensed font (34.1%), and use of portrait format (81.9%) (P ≤.015). Otherwise, line length significantly decreased to on average 62.6 characters per line (P =.012) and the classes of fonts used remained almost unchanged.
Conclusion
To achieve any further increase of package leaflet font size and other typographic improvements, a significant decrease in text volume is essential. To this end, replacing the current 840-word QRD template with a 200-word version would allow optimization of typography in all package leaflets, without deleting information essential for patients or incurring any unfavorable format increase.
Similar content being viewed by others
References
European Parliament and Council of the European Union, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. OJ 2001;L311:67. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf. Accessed October 18, 2016.
European Commission. A guideline on the readability of the label and package leaflet of medicinal products for human use, Brussels, 29. September 1998. http://www.pharma-eu.com/pdfs/Guideline%20on%20Readbaility%20EMEA.pdf. Accessed October 18, 2016.
European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use, Revision 1, 12 January 2009. http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed October 18, 2016.
The European Parliament and the Council of the European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJ 2010;L348:74–99.
European Commission — CHAFEA. Specific contracts awarded under framework contracts in 2011 http://ec.europa.eu/chafea/health/sc_awarded_under_fwc_2011.html. Accessed October 18, 2016.
van Dijk L, Monteiro S, Vervloet M, de Bie J, Raynor D. Study on the package leaflets and the summary of product characteristics of medicinal products for human use (PIL-study). http://ec.europa.eu/health/files/committee/75meeting/pil_s.pdf. Accessed October 18, 2016.
Fuchs J, Werner S, Scheunpflug C, et al. Excessive medical information increase in package leaflets. Int J Clin Pharmacol Ther. 2010;48:781–790.
British Standards Institution Luc Devroye. British Standard 2961: Typeface Nomenclature and Classification, London, edition 1967.
IMS Institute for Health informatics. The role of generic medicines in sustaining healthcare systems: a European perspective. http://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS_Health_2015_-_The_Role_of_Generic_Medicines_in_Sustaining_Healthcare_Systems_-_A_European_Perspective.pdf. Published June 2015. Accessed October 19, 2016.
Fuchs J, Heyer T, Langenhan D, Hippius M. New font size requirements in package leaflets of medicines. Pharm Ind. 2010;72:2032–2036.
Tinker M, Paterson D. Studies of typogrophical factors influencing speed of reading—V. Simultaneous variation of type size and line length. J Appl Psychol. 1931;15:72–78.
Bernardini C, Ambrogi V, Fardella G, Perioli L, Grandolini G. How to improve the readability of the patient package leaflet: a survey on the use of colour, print size and layout. Pharmacol Res. 2001;5:437–443.
Tinker M, Paterson D. Speed of reading nine point type in relation to line width and leading. J Appl Psychol. 1949;33:81–82.
Deutsches Institut für Normung. DIN 1450:2013-04: Schriften — Leserlichkeit. Berlin: Beuth Verlag; 2013. http://www.beuth.de/de/erweiterte-suche/81186!search?query=DIN+1450&dokNr=&ausgabeDatum=&hitsPerPage=10&searchSubmit=suchen&alx.searchType=complex. Accessed October 19, 2016.
Fuchs J. The way forward in package leaflet user tests from a CRO’s perspective. Drug Inform J. 2010;44:119–129.
Wolf A, Fuchs J, Schweim H. Readability of the European QRD template—the European QRD template version 8 in comparison to its predecessor and a shorter model template. Pharm Ind. 2014;76:1312–1322.
Pander Maat H, Lentz L. Improving the usability of patient information leaflets. Patient Educ Counsel. 2010;80:113–119.
Tinker MA, Paterson DG. Influence of type form on speed of reading. J Appl Psychol. 1928;12:359–368.
Breland K, Breland MK. Legibility of newspaper headlines printed in capitals and in lower case. J Appl Psychol. 1944;28:117–120.
Poulton E, Brown C. Rate of comprehension of an existing teleprinter output and of possible alternatives. J Appl Psychol. 1968;52:16–21.
Wolf A, Fuchs J, Schweim H. Implementation of the European QRD template in package leaflets of centralized approved medicines. Therapeutic Innovation & Regulatory Science. 2016;50:106–114.
Fuchs J, Banow S, Görbert N, Hippius M. The importance of package leaflet information in the European Union. Pharm Ind. 2007;69:165–172.
Fuchs J, Scheunpflug C, Götze E. The influence of the European Union’s QRD template on the use of package leaflets compared with a shorter model template. Pharm Ind. 2012;74:126–136.
Wolf A, Fuchs J, Schweim H. QRD template texts intended for package leaflets/development from the first QRD template up to the new draft of July 2012. Pharm Ind. 2012;74:1540–1549.
Fuchs J, Hippius M. Inappropriate dosage instructions in package leaflets. Patient Educ Counsel. 2007;67:157–168.
Hartley J, Johnson M. Portrait or landscape? Typographical layouts for patient information leaflets. Visible Language. 2000;34:296–309.
Fuchs J, Götze EA, Voigt C. Landscape versus portrait format in package leaflets: which format is more suitable according to readability test results from the PAINT3 study? Pharm Ind. 2016;78:1178–1184.
Gregory M, Poulten E. Even versus uneven right-hand margins and the rate of comprehension in reading. Ergonomics. 1970;13:427–434.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Fuchs, J., Kraft, S., Vettermann, A. et al. Typographic Changes in Package Leaflets of the European Union Based on the Example of German Versions Between 2005 and 2015. Ther Innov Regul Sci 51, 431–438 (2017). https://doi.org/10.1177/2168479017699654
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479017699654